PONSTAN mefenamic acid 250mg capsule blister pack

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

mefenamic acid, Quantity: 250 mg

Dostupno od:

Pfizer Australia Pty Ltd

INN (International ime):

Mefenamic acid

Farmaceutski oblik:

Capsule, hard

Sastav:

Excipient Ingredients: Gelatin; carbon black; iron oxide yellow; brilliant blue FCF; lactose monohydrate; titanium dioxide

Administracija rute:

Oral

Jedinice u paketu:

50

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

Treatment of primary dysmenorrhoea and primary menorrhoea. Short-term relief of mild to moderate pain such as dental pain and soft tissue pain.

Proizvod sažetak:

Visual Identification: An aqua blue/ivory opaque hard gelatin capsule printed 'PARKDAVIS' reverse logo on body and cap in black.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 30 Months; Container Temperature: Store below 30 degrees Celsius

Status autorizacije:

Licence status A

Datum autorizacije:

2014-07-29

Uputa o lijeku

PONSTAN
® CAPSULES
_Mefenamic Acid_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PONSTAN.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking PONSTAN
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PONSTAN IS
USED FOR
PONSTAN is used to relieve the
symptoms of period pain and treat
heavy periods.
It also provides short term relief of
pain in conditions such as:
•
muscle and joint injuries such as
sprains, strains and tendonitis
•
dental pain.
PONSTAN containing mefenamic
acid belongs to a group of medicines
called Non-Steroidal Anti-
Inflammatory Drugs (or NSAIDs).
These medicines work by relieving
pain and inflammation.
Although PONSTAN can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Your doctor may have prescribed
PONSTAN for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PONSTAN
HAS BEEN PRESCRIBED FOR YOU.
PONSTAN is not addictive.
BEFORE YOU TAKE
PONSTAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE PONSTAN IF:
1.
YOU HAVE AN ALLERGY TO:
•
mefenamic acid or any of the
ingredients listed at the end of
this leaflet
•
aspirin
•
any other NSAID medicine
including COX-2 inhibitors.
Many medicines used to treat
headache, period pain or other aches
and pains contain aspirin or NSAID
medicines.
IF YOU ARE NOT SURE IF YOU ARE
TAKING ANY OF THESE MEDICINES, ASK
YOUR DOCTOR OR PHARMACIST.
Symptoms of an allergic reaction to
these medicines may include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or
tongue which may cause
difficulty in swallowing or
breathing
•
hives, itching or skin rash
•
fainting.
If you are allergic to aspirin or
NSAID medicines and ta

Svojstava lijeka

Version: pfpponsc10921
Supersedes: pfpponsc10520
Page 1 of 13
AUSTRALIAN
PRODUCT
INFORMATION
–
PONSTAN
® (MEFENAMIC ACID) CAPSULES
1.
NAME OF THE MEDICINE
Mefenamic acid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PONSTAN capsules contain the active ingredient mefenamic acid 250
mg/capsule.
EXCIPIENT(S) WITH KNOWN EFFECT
•
Lactose monohydrate
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Hard capsule.
PONSTAN capsules have an opaque aqua blue cap and opaque ivory body
with “PARKE
DAVIS” printed in black on both the body and cap.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of primary dysmenorrhoea and primary menorrhagia.
Short-term relief of mild to moderate pain such as dental pain and
soft tissue pain.
4.2 DOSE AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms.
Patients on long term treatment should be reviewed regularly with
regards to efficacy, risk
factors and ongoing need for treatment.
Pregnancy: see Section 4.6 Fertility, pregnancy and lactation.
DYSMENORRHOEA
2 capsules (500 mg) three times daily with meals from the onset of
pain and continued for the
usual duration of pain.
Version: pfpponsc10921
Supersedes: pfpponsc10520
Page 2 of 13
MENORRHAGIA
2 capsules (500 mg) three times daily with meals and from the onset of
menses and continued
according to the judgement of the physician. Therapy should not be
continued for more than
7 days except on the advice of a physician.
OTHER INDICATIONS
2 capsules (500 mg) three times daily, with meals.
4.3 CONTRAINDICATIONS
1.
Patients showing evidence of chronic inflammation and/or active
ulceration of either the
upper or lower gastrointestinal tract and patients with pre-existing
renal disease.
2.
Patients in whom aspirin and/or other non-steroidal anti-inflammatory
drugs (NSAIDs)
have induced symptoms of bronchospasm, allergic rhinitis or urticaria,
because the
potential exists for cross